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Evidence in Balneology – the current situation
Christoph Gutenbrunner
Christoph Gutenbrunner, MD, PhD, Professor Department for Physical Medicine and RehabilitationInstitute for Balneology and Medical ClimatologyHanover Medical SchoolD-30625 [email protected]
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Overview
Introduction: aims and problems Balneology – the problem of definitions Systematic approach to classify studies in Balneology
Examples for randomized and non-randomized controlled studies in Balneology and Health Resort Medicine◦ cardiovascular risk factors◦ muskuloskeletal diseases ◦ psoriasis
Meta-analyses any systematic reviews Conclusion
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Introduction: aims and problems
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Aims
look for published data on the evidence of balneotherapy in health conditions
including both:◦ serial intervention of single treatment modality
◦ complex health resort treatments
excluding: ◦ effects of single interventions on symptoms
look for meta-analyses on these effects
but not: looking for evidence of efficacy of involvement of PRM specialists into health resort treatments
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Problems
To show the efficacy of a specialty in general (e.g. PRM) or a field or sub-field (e.g. Balneology) may be an illusion◦ are surgeons efficient?◦ is drug treatment efficient?
Clinical evidence can only be proven of ◦ one agent◦ one way of application and◦ one health condition
Most therapeutic agents in balneology cannot be proven in double-blind studies Balneotherapy mostly is used in comprehensive concepts Internationally agreed definitions in Balneology are still lacking
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Balneology: the problem of definitions
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Balneotherapy: modalities
Substances, e.g.:◦ Mineral waters (Na, Ca, Mg, Cl, SO4, H2S, CO2, trace elements)
◦ gases (CO2, H2S, Rn) ◦ peloids (mud, peat, fango and others)
Modes of application, e.g.: ◦ bathing◦ drinking◦ inhalation
Dosage, e.g.: ◦ single use◦ series◦ combination
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Lack of uniform definitions
The term “Hydrotherapy” is not defined consistently all over the world, e.g.◦ UK: exercise in pools◦ Germany: treatments according to Kneipp and related
applications of water
Related terms are: ◦ balneotherapy, crénotherapy ◦ physiotherapy◦ naturopathy
The lack of consistent definition is a significant barrier for research especially for meta-analyses in the field of hydrotherapy and balneotherapy
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Meta-analysis in Balneology
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Possible Solution
To better understand the problem on terms:◦ differentiate between object and term◦ Accept scientific language (English) and
translate to national languages
Agree on definitions and English terms: ◦ a proposal will be published soon◦ use uniform keywords along these definitions
Reflect the question asked:◦ evidence of efficacy of a specific modality (therapeutic
substance and mode of application): clinical trials, metananlyses
◦ or: efficacy of balneology in general: health care research
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Proposal for definitions
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Use of terms
Wälde & Guten-brunner 2009
(unpublished)
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Systematic approach to classify studies in Balneology
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Structure of Sciences: clinical sciences
Biosciences, Physiology
Cell
Society
Basic Sciences Applied Sciences Clinical Sciences
Social Sciences, Epidemiology
Rehabilitation system sciences
Biomedical Sciences,
Technology
Clinical Sciences
Stucki G, Grimby G: J Rehabil Med 2007; 39: 293-298, modified
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Examples for randomized and non-randomized controlled studies in Balneology and Health Resort Medicine
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Example 1: cardiovascular risk factor profile
Parameter p-value ( T1-T2) p-value ( T1-T3)
Overall effect p = 0,000*) p = 0,020*)
BMI [kg/m2] p = 0,000**) p = 0,021**)
Apolipoprotein B [mg/dl] p = 0,015**) p = 0,008**)
Fasting insulin [mg/dl] p = 0,035**) p = 0,034**)
Fibrinogen [mg/dl] p = 0,950**) p = 0,215**)
Mean arterial blood pressure [mmHg] p = 0,002**) p = 0,101**)
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
-15
-10
-5
0
5
10
p<0,05
[mg/dl]
Change of Apolipo-protein B
diffe
renc
e
control group (n=82)
study group (n=71)
0,0
0,1
0,2
0,3
0,4
0,5
0,6
T1-T2 T1-T3T1-T2 T1-T3
Effect size
effe
ct s
ize
Gutenbrunner et al.: Phys Med Rehab Kuror 2001; 12: 272-283
Example 1: cardiovascular risk factor profile
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Example 3: Fibromyalgia
0 1 2 3 4 5 6 7 8 9 10 11 12 13
25
30
35
40
45
50
55
n.s.
p<0,05p<0,05
Treatment period
n.s.
p<0,001
FibromyalgiaImpactQuestionnaire (FIQ)
[Score]
Thermal pool baths (n=16)
No baths (n=13)(Dönmez et al. 2005)
Months after start of treatment
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Example 4: Low Back Pain
0 1 2 3 4
-1
0
1
2
3
4
5
6
7
8
p<0,01
Treatment period
p<0,01
VisualAnalogueScale(Pain)(Patients with cLBP)
[Score]
Mineral water baths (n=30)
Tap water baths (n=30)Balogh et al. 2005)
Months after start of treatment
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Example 5: Psoriasis
Brockow T et al.; J Altern Compl Med 2007; 13: 725-732
Methods: ◦ 160 patients with PASI of >10 (4 German spa centers)◦ randomly allocated to UVB + sodium chloride bath (25% -
27%) or UVB only 3 a week until remission (PASI < 5) or for a maximum of 6 weeks
◦ outcome definition: reduction of PASI >= 50% Results:
◦ Participants allocated to HC-SSW-UVB attained to a statistically significantly higher rate of PASI-50 than patients allocated to UVB only (86% vs. 54%; p < 0.001) ◦
number needed to treat: 3.1 (95% confidence interval, 2.1-6.0) ◦ Postintervention analysis: no clear persisting effect. Conclusion: The study indicates that HC-SSW-UVB are superior to
routine UVB at the end of a 6-week treatment course
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Example 6: Anxiety disorder
Dubois et al.: www,afreth.fr
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
RCT with 237 patients with
anxiety
◦ cure thermale: n=120
◦ anxiolytic drug
(Paroxetine): n=117
follow-up: 24 months(Dubois et al. 2009; www. afreth.fr)
Example 6: Anxiety disorder
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Meta-analyses and systematic reviews
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Meta-analysis
Pittler et al., Rheumatol 2006 published online
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Pool-Exercise in Fibromyalgia
Gowans SE, deHueck A: Pool exercise for individuals with fibromyalgia. Curr Opin Rheumatol. 2007 Mar; 19(2): 168-73Purpose of the Review: […] Recently, there have been a number of randomized controlled trials that evaluate the benefits of pool exercise for fibromyalgia. This review will integrate the results of eight pool exercise studies that have been published in the last 7 years. Recent Findings: Pool exercise has been evaluated against sedentary control groups, land-based exercise and immersion in a warm, mineralized pool. Pool exercise has been shown to be as effective as land-based exercise and may have greater benefits with respect to mood and sleep duration. Based on follow-up studies, exercise-induced improvements in physical function, pain and mood may persist for up to 2 years. […] Summary: Pool exercise can be an effective intervention for individuals with fibromyalgia. […]
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Review: Therapeutic effect of Balneology
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Review: Therapeutic effect of Balneology
Study design: Systematic review Search: ◦ PubMed Scopus & Cochrane library (1950–2006), ◦ RCTs
◦ clinical effects of Balneotherapy (both as a solitary approach and in the context of spa) ◦ various diseases Results: ◦ 203 potentially relevant articles; 29 RCTs evaluated:
- N=22 (75.8%) rheumatological diseases (8 osteoarthritis, 6 fibromyalgia, 4 ankylosing spondylitis,
4 rheumatoid arthritis) - N=3 (10.3%) other musculoskeletal diseases (cLBP)
◦ 1,720 patients with musculoskeletal diseases were evaluatedFalagas et al., Int J Clin Pract, 2009; 63 (7): 1068–1084
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Review: Therapeutic effect of Balneology
Results: ◦ in 17 studies (68%) Balneotherapy did result in more pain
improvement in patients with rheumatological diseases and chronic low back pain as compared to the controls
◦ in 8 studies, pain was improved in the Balneotherapy treatment arm, but this improvement was statistically not different than that of the Controls
◦ the beneficial effect lasted for different periods of time:10 days (1) 2 weeks (1), 3 weeks (1), 12 weeks (2), 3 months (11), 16–20 weeks (1), 24 weeks (3), 6 months (3) 40 weeks (1), 1 year (1)
Conclusion: The available data suggest that Balneotherapy may be truly associated with improvement in several rheumatological diseases. However, existing research is not sufficiently strong to draw firm conclusions.
Falagas et al., Int J Clin Pract, 2009; 63 (7): 1068–1084
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Conclusion
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Conclusion
To prove efficacy of Balneology as a whole is a question of health care research (not of clinical trials)
Studies can prove efficacy of one modality or concept in a specific health condition only
Internationally agreed definitions in Balneology are needed and should be used
Some clinical trials exist showing efficacy, e.g.◦ cardiovascular risk factor profile◦ muscolo-skeletal diseases◦ psoriasis◦ psyciatric disorders
Some meta-analyses and systematic reviews are available now More randomized controlled studies are needed
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Evidence in Balneology – the current situation Christoph Gutenbrunner 17th European Congress on PRMVenice, May 23 -26, 2010
Thank you for your attention
Christoph Gutenbrunner, MD, PhD, Professor Department for Physical Medicine and RehabilitationInstitute for Balneology and Medical ClimatologyHanover Medical SchoolD-30625 [email protected]